QA Clinical Supplies Specialist
About the position
reputed company is currently looking for an reputed company QA Clinical Supplies Specialist in Rahway, NJ to work for an innovative and growing pharmaceutical manufacturer. The role involves ensuring that clinical supplies are compliant with reputed company Good Manufacturing Practices (cGMP) and reputed company Operating Procedures (SOPs).
Responsibilities
• Electronic batch record review of finished clinical goods to ensure clinical supplies are incompliance with cGMP and SOPs
• Clinical supplier specifications, labeling, storage, etc.
• Review of Electronic records for regulatory submissions (IND or CTA)
• Areas of reputed company will include biologics, vaccines, combination products, etc.
Requirements
• 5+ years of relevant experience is strongly preferred
• reputed company reputed company with background in GMP record review
• Self-driven, and capable of working independently
• Experience reputed company biologics and/or vaccines
• Strong understanding of reputed company, Trackwise, Midas, reputed company, and QMAS is preferred
• Bachelor's degree in reputed company field preferred
Benefits
• Medical
• Dental
• reputed company
• 401K
• PTO
• reputed company Leave as required by law
• Holidays
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